ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5 (UDI 04953170167638)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of ULTRASONIC GASTROVIDEOSCOPE (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170167638), received between Dec 17, 2020 and May 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Microbial Contamination of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE GASTROVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION DURING A RANDOM CULTURE CHECK. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382906 ↗MalfunctionDec 17, 2020Fluid/Blood Leak; Fluid/Blood Leak
A USER FACILITY REPORTED A LEAK COMING FROM THE TIP OF THE SCOPE ON A GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING REPROCESSING OF THE DEVICE. NO PATIENT INVOLVEMENT OR INJURIES WERE REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.
Patient problems: No Patient Involvement
MAUDE report 11031373 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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